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PubMed2006

Augmentation of implant purchase with bone cements: an in vitro study of injectability and dough distribution.

Vertebroplasty is widely used to treat (augment) osteoporotic fractures of the spine. This technique--with or without metallic implants--might have more widespread indications, if the mechanics of the injection and distribution of the cement dough through cannulated instruments and implants were better understood. This study was performed to investigate injectability of calcium phosphate and acrylic bone cements through implant prototypes, which featured different perforated sleeve designs. Using a custom-made capillary rheometer, the forces needed to inject 10 mL of the cement dough through standard cannulas were measured in the first series of experiments. In the second series, plastic sleeves were attached to the rheometer, simulating the implant. In both series, the dough was injected into ambient laboratory atmosphere, and in the second series, cement distribution was analyzed by means of an optical system. Injection of cement dough through the cannulas required forces between 50 and 400 N in the case of acrylic cements and between 40 and 500 N in case of the calcium phosphate cements. Using different sleeves did not have a significant influence on the distribution of the cement dough around the sleeve. The amount of cement dough injected was reduced when a perforated implant was attached to the cannula. More material was delivered through the proximal holes of the implant, leading to a V-shaped distribution of the cement dough. Among topics to be investigated in future studies is determination of the injectability of cement dough into trabecular bone or bone-like structures.

Biocompatible Materials↗
PubMed1998

Long-term elution of antibiotics from bone-cement: an in vivo study using the prosthesis of antibiotic-loaded acrylic cement (PROSTALAC) system.

A prospective study of 49 patients undergoing a modified 2-stage exchange arthroplasty for infected total hip and knee arthroplasties using the prosthesis of antibiotic-loaded acrylic cement (PROSTALAC) system with a variety of doses of tobramycin and vancomycin was performed. The intra-articular concentrations of tobramycin and vancomycin were measured at the time of removal of the PROSTALAC temporary spacer and reimplantation of a definitive joint arthroplasty prosthesis, at a mean 118 days following initial implantation. The 95% confidence interval of the intra-articular concentration of tobramycin (4.35-123.88 mg/L) was entirely above the breakpoint sensitivity limit for sensitive organisms when at least 3.6 g of tobramycin was used per package of bone-cement but was entirely below it when at most 2.4 g was used. Vancomycin elution was not as good; however, detectable levels were still present in most patients. There was a statistically significant increase in the elution of vancomycin when the dose of tobramycin was increased from at most 2.4 g to at least 3.6 g. The dose of vancomycin in the cement did not influence the elution of either tobramycin or vancomycin. On the basis of these results, the use of at least 3.6 g of tobramycin and 1 g of vancomycin per package of bone-cement is recommended when antibiotic-loaded cement spacers are used in 2-stage exchange arthroplasty for infected total hip and knee arthroplasties.

Anti-Bacterial Agents↗
PubMed1993

Antibiotic-loaded biodegradable bone cement for prophylaxis and treatment of experimental osteomyelitis in rats.

A biodegradable, particulate composite bone cement containing gentamicin and vancomycin was used for both treatment and prophylaxis of Staphylococcus aureus osteomyelitis in rats. Osteomyelitis was established by inoculating S. aureus into holes that were drilled in the proximal tibiae and were filled with polymethylmethacrylate (PMMA) cylinders. The cylinders were left in place for 3 weeks. The infections were serially evaluated by clinical and radiographic examination and by quantitative culture for colony forming units (CFUs) at the time the rats were killed. For treatment, cements containing antibiotic were implanted in animals that had established osteomyelitis and were left in place for an additional 3 weeks. Sites treated with biodegradable cement containing antibiotics exhibited significantly fewer CFUs in comparison with controls (p < 0.01). Sites treated prophylactically with the biodegradable cement developed no infections as evaluated by clinical or radiographic criteria or by quantitative culture. At this relatively early time, no significant difference in therapeutic effectiveness was found when either the biodegradable cement or PMMA was used as a carrier for antibiotics.

Animals↗
PubMed1977

The bone-cement interface temperature during total joint replacement.

Sets of thermoprobe measurements of the temperature of the bone-cement interface were made during twenty total joint-replacement procedures. Although the range of rise in temperature was wide, from 3 to 17 degrees centigrade, the highest temperature obtained was 48 degrees centigrade, which is well below the denaturation point (56 degrees centigrade) of proteins. Several factors, such as the presence of blood and moisture at the interface and the large surface area and poor heat conductivity of methylmethacrylate, prevent the interface from experiencing the high rise in temperature that occurs at the center of the polymerizing cement mass.

Bone Cements↗
PubMed1983

Pathogenesis of circulatory reactions triggered by nervous reflexes during the implantation of bone cements.

Circulatory and respiratory reactions during the implantation of joint endoprostheses have been observed for years. The components of the bone cements used for anchoring (methyl methacrylate monomer) or the outpour of bone marrow substances from the affected bone marrow cavity are thought to be chiefly responsible for these effects. However, our previous investigations demonstrated unambiguously that reactions of this type can be attributed to direct nervous-reflex mechanisms triggered by the pressure rise in the medullary canal, and that, in addition, bone marrow embolism plays a part in serious circulatory incidents. The investigations on which the present paper is based have confirmed the mechanism of circulatory reactions triggered by direct nervous reflex and have shown once again that the release of cement monomers is not of any significance, at least not in animal experiments. In regard of the characteristics of these reflex processes, it has been possible to show by both surgical and pharmacologic interventions in the vegetative nervous system, performed before and during pressure experiments, that these reflex processes are caused not so much by an increase of the vagus tone as by a central inhibition of the sympathicus. Neither administrations of atropine nor bilateral cervical vagotomy are able to prevent the reactions. This was only possible under the influence of a ganglion blocker.

Animals↗
PubMed1977

[A ceramic total hip endoprosthesis for implantation without bone cement. Preliminary report (author's transl)].

A new total hip endoprosthesis for implantation without bone cement is reported. This prosthesis consists of a ceramic socket and a titanium femoral component which is covered with a ceramic layer (Al2O3). The proximal end of the femoral component is shaped to a conus on which a ceramic ball for articulation with the socket is placed. Beside the construction principles the implantation technique and first clinical experiences are described.

Bone Cements↗
PubMed2003

Antibiotic prophylaxis in total hip arthroplasty: effects of antibiotic prophylaxis systemically and in bone cement on the revision rate of 22,170 primary hip replacements followed 0-14 years in the Norwegian Arthroplasty Register.

We studied the effects of antibiotic prophylaxis, systemically and in bone cement, on the revision rate of cemented total hip arthroplasties (THAs) in data from the Norwegian Arthroplasty Register during the period 1987-2001. To have comparable groups, only THAs performed because of primary osteoarthritis, using cemented implants with documented good results, and high-viscosity cement were included. If systemic antibiotic prophylaxis had been given, only operations with cephalosporin or penicillin were selected. Cox-estimated survival relative revision risks (RR) are presented with adjustment for differences among groups in gender, age, cement brand, type of systemic antibiotic prophylaxis, type of prosthesis, type of operating room, and duration of the operation. Of 22,170 THAs studied, 696 THAs (3.1%) were revised, 440 (2.0%) for aseptic loosening and 102 (0.5%) for deep infection. We found the lowest risk of revision when the antibiotic prophylaxis was given both systemically and in the cement (15,676 THAs). Compared to this combined regime, patients who received antibiotic prophylaxis only systemically (5,960 THAs) had a 1.4 times higher revision rate with all reasons for revision as endpoint (p = 0.001), 1.3 times higher with aseptic loosening (p = 0.02) and 1.8 times higher with infection as the endpoint (p = 0.01). With the combined antibiotic regime, the results were better if antibiotics were given 4 times on the day of surgery (2,194 THAs), as compared to once (1,424 THAs) (p < 0.001), twice (2,680 THAs) (p < 0.001), or 3 times (5,522 THAs) (p = 0.02). Those who received systemic prophylaxis a single day 1, 2 or 3 times, as compared to 4 times, had a revision rate 1.8-3.5 times higher with all reasons for revision as endpoint, 1.5-3.1 times higher with aseptic loosening, and 2.7-6.8 times higher with infection. When we compared systemic prophylaxis 4 times in 1 day, no further improvement resulted in those given systemic prophylaxis for 2 days (1,928 THAs) or 3 days (717 THAs). In a subset of data including only the Charnley prosthesis, we obtained similar results. This observational study shows that the best results were recorded when antibiotic prophylaxis was given both systemically and in the bone cement, and if the systemic antibiotic was given 4 times on the day of surgery.

Adolescent↗
PubMed2005

An articulated antibiotic spacer used for infected total knee arthroplasty: a comparative in vitro elution study of Simplex and Palacos bone cements.

For the staged management of infected total knee arthroplasty (TKA), antibiotic laden polymethylmethacrylate (PMMA) spacers have been recommended. Antibiotic-impregnated PMMA spacers target drug delivery, achieving high local levels while limiting the potential for host toxicity associated with parenteral antimicrobial therapy. This study examined the elution characteristics of an articulating PMMA TKA spacer that has been useful clinically. Tobramycin and vancomycin are both active against many organisms leading to joint infections. We used various combined antibiotic concentrations (maintaining a relative ratio of 55% tobramycin to 45% vancomycin w/w), and then assayed the elution profile of the TKA spacer in vitro. Additionally, the elution qualities of two brands of bone cement, Simplex and Palacos, were compared. Briefly, three groups of PMMA spacers, impregnated with different antibiotic loads, were fashioned from a mold replicating a femoral TKA component. The entire spacer surface area was immersed in sterile phosphate buffered saline (PBS) in a 1:6 ratio of grams of cement to milliliters of PBS and incubated at 37 degrees C for 24 h. After 24 h, aliquot eluates were taken, the PBS discarded, and replaced with fresh, sterile PBS. PBS was changed daily and an aliquot was taken at least weekly for nine weeks. Eluate samples were stored at -70 degrees C until assayed. Each spacer eluate sample's antibiotic concentration was determined by disc diffusion bioassay against Bacillus subtilis. Mean zone inhibition diameters were extrapolated from the standard curve to yield micrograms per milliliter of antibiotic in PBS. In all groups the Palacos spacers demonstrated higher elution levels, above the MIC for the organism used, for a longer period of time than those made with Simplex. Based on the observed elution profiles, antibiotic-impregnated Palacos bone cement may offer a more effective vehicle for local drug delivery during staged treatment of infected TKA.

Arthroplasty, Replacement, Knee↗
PubMed2005

Acrylic bone cement: clinical development and current status in North America.

This article discusses issues surrounding acrylic bone cement and covers functional results, mechanism and definition of failure, design issues, wear and alternate bearing surfaces, revision, and evolution of concepts regarding infection, dislocation, thromboembolic issues, surgical approach, bone loss and bone grafts, and finally a couple of problems the author sees for the future.

Arthroplasty, Replacement↗
PubMed2006

Effects of porosity on the fatigue performance of polymethyl methacrylate bone cement: an analytical investigation.

Porosity has been shown to affect the fatigue life of bone cements, but, although vacuum mixing is widely used to reduce porosity in the clinical setting, results have been mixed and the effects of porosity are not well understood. The aim of this study was to investigate the effects of porosity using stress analysis and fracture mechanics techniques. The stress concentrations arising at voids in test specimens were found using analytical solutions and boundary element methods. The fatigue life of specimens containing voids of various sizes was predicted using fracture mechanics techniques. For spherical voids that do not occupy a significant proportion of the cross-section, the resulting stress concentration is independent of void size and too small to account for the observed crack initiation. Cracks must therefore initiate at additional stress raisers such as radiopacifier particles or additional voids. For large voids, the stress increases as the remaining cross-section of the specimen decreases, and this may account for much of the observed reduction in fatigue strength in hand-mixed cement. Although crack initiation may be largely independent of void size, there is an effect on crack growth rate. Cracks are predicted to grow faster around larger voids, since they remain in the stress concentration around the void for longer. This effect may account for the relationship between porosity and fatigue life that has been observed in samples without large voids. Since porosity appears to affect crack growth more than initiation, it may be less damaging in high-cycle clinical fatigue, which may be predominantly initiation controlled, than in short laboratory tests.

Bone Cements↗
PubMed2005

Influence of the method of blending an antibiotic powder with an acrylic bone cement powder on physical, mechanical, and thermal properties of the cured cement.

Two variants of antibiotic powder-loaded acrylic bone cements (APLBCs) are widely used in primary total joint replacements. In the United States, the antibiotic is manually blended with the powder of the cement at the start of the procedure, while, in Europe, pre-packaged commercially-available APLBCs (in which the blending is carried out using an industrial mixer) are used. Our objective was to investigate the influence of the method of blending gentamicin sulphate with the powder of the Cemex XL formulation on a wide collection of properties of the cured cement. The blending methods used were manual mixing (the MANUAL Set), use of a small-scale, easy-to-use, commercially-available mechanical powder mixer, OmoMix 1 (the MECHANICAL Set), and use of a large-scale industrial mixer (Cemex Genta) [the INDUSTRIAL Set]. In the MECHANICAL and MANUAL Sets, the blending time was 3 min. In preparing the test specimens for each set, the blended powder used contained 4.22 wt% of the gentamicin powder. The properties determined were the strength, modulus, and work-to-fracture (all obtained under four-point bending), plane-strain fracture toughness, Weibull mean fatigue life (fatigue conditions: +/-15 MPa; 2 Hz), activation energy and frequency factor for the cement polymerization process (both determined using differential scanning calorimetry, at heating rates of 5, 10, 15, and 20 Kmin(-1)), the diffusion coefficient for the absorption of phosphate buffered saline, PBS, at 37 degrees C, and the rate of elution of the gentamicin into PBS, at 37 degrees C (E). Also determined were the particle size, particle size distribution, and morphology of the blended powders and of the gentamicin. For each of the cured cement properties (except for E), there is no statistically significant difference between the means for the 3 cements, a finding that parallels the observation that there are no significant differences in either the mean particle size or the morphology of the blended cement powders. Notwithstanding these results, it is suggested that when the powder mixture is blended in the operating room, using the OmoMix 1 is more likely to produce a more consistent and reproducible mixture than when manual mixing is used.

Absorption↗
PubMed1998

Limited compliance of some apatitic calcium phosphate bone cements with clinical requirements.

Clinical requirements for calcium phosphate bone cements were formulated in terms of the initial setting time, the final setting time, the cohesion time and the ultimate compressive strength. Two cements were tested. Biocement H was made of a powder containing alpha-tertiary calcium phosphate and precipitated hydroxyapatite. Biocement F was made of a powder containing, in addition, some monetite. The liquid/powder (L/P) ratio was varied over the range 0.30-0.40 ml g(-1), whereas the accelerator concentration in the liquid was varied from 0%-4% Na2HPO4 in water. For Biocement H there was no combination L/P ratio and % Na2HPO4 for which all clinical requirements were satisfied. However, Biocement F had a certain area where this was the case. Therefore, it is expected that Biocement F can be applied in clinical situations such as orthopaedics, plastic and reconstructive surgery and oral and maxillofacial surgery, even when early contact with blood is inevitable.

Journal Article↗
PubMed2005

Anterior spinal column augmentation with injectable bone cements.

A vertebral fracture, whether originating from osteoporosis or trauma, can be the cause of pain, disability, deformation and neurological deficit. The treatment of vertebral compression fractures has, for many years until the advent of vertebroplasty, consisted of bedrest and analgesics. Vertebroplasty is a percutaneous technique during which bone cement is injected in a vertebral body to provide immediate pain relief by stabilization. Inflatable bone tamps can, prior to the injection of cement, be used to create a void in the vertebral body, in which case the technique is known as balloon vertebroplasty (or kyphoplasty). The chance of extracorporal cement leakage is smaller for balloon vertebroplasty than for vertebroplasty. Some authors also claim to have gained some correction in vertebral body height or angulation. Both interventions can be used for several indications, including osteoporotic compression fractures and osteolytic lesions of the vertebral body such as myeloma, hemangioma or metastasis, and also for traumatic burst fractures in combination with pedicle screw instrumentation. Polymethyl methacrylate cement is the bone void filler that is used most frequently, although the application of calcium phosphate cements has been studied widely in vitro, in vivo and also in small-scale clinical series. The clinical results of (balloon-) vertebroplasty are favorable with 85-95% of all patients experiencing immediate and long-lasting relief of pain. Serious complications are relatively rare but include neurological deficit and pulmonary embolism. In this paper, both vertebroplasty and balloon vertebroplasty and their respective indications, techniques and results are described in relation with the application and limitations of permanent and resorbable injectable bone cements.

Absorbable Implants↗
PubMed2004

Endogenous cannabinoids are candidates for lipid mediators of bone cement implantation syndrome.

Acute hypotension, hypoxemia, cardiac arrhythmias, cardiac arrest, (or a combination of these), and sudden death are well-recognized complications of the cemented hip arthroplasty procedure. Collectively, these are known as the bone cement implantation syndrome (BCIS). The endogenous cannabinoids, anandamide (ANA) and 2-arachidonylglycerol (2-AG), are reported to be strong vasodilators and play a role in the hypotension associated with hemorrhagic and septic shock. In the present study, a potential role for the endogenous cannabinoids in influencing hemodynamic variables in BCIS was investigated. Thirty-five patients (35 hips) entered a prospective, randomized clinical trial. The patients were divided into two groups. Group 1 comprised 16 patients who had the component inserted using a conventional cementing technique, whereas group 2 consisted of 19 patients who had the femoral component inserted without cement. Blood samples were taken at six consecutive time points: before anesthesia, after reaming the femur, 2 min after insertion of stems with or without cement into the femur, and 10 min, 20, and 30 min after stem insertion. In group 1 (with cement), the mean levels of ANA and 2-AG significantly increased after stem insertion. In a comparison of each group after stem insertion, mean ANA and 2-AG levels in group 1 also significantly differed from those in group 2. By contrast, in group 2 (without cement) neither ANA nor 2-AG levels exhibited a significant increase or change at any point in time. In conclusion, we have shown for the first time that endogenous cannabinoids are candidates for lipid mediators of BCIS.

Aged↗
PubMed1997

Mechanical and biological properties of bioactive bone cement containing silica glass powder.

Silica glass powder (SG-P) made by a fusing-quenching method was added as a second filler to a bioactive bone cement consisting of MgO-CaO-SiO2-P2O5-CaF2 apatite and wollastonite containing glass-ceramic powder (AW-P) and bisphenol-a-glycidyl methacrylate (Bis-GMA)-based resin, to achieve a higher mechanical strength and better handling properties in use. Five types of cement were used, containing different weight ratios of AW-P/SG-P (Group 1 = 100/0; Group 2 = 75/25; Group 3 = 50/50; Group 4 = 25/75; and Group 5 = 0/100) as filler, to evaluate the effect of SG-P content on the biological, mechanical, and handling properties. The total proportion of filler added to the cements was 85% w/w. The compressive, bending, and tensile strengths and fracture toughness of the cements increased with SG-P content. The viscosity of cements also increased with SG-P content, and every cement could be handled manually. The cements were evaluated in vivo by packing the intramedullary canals of rat tibiae. An affinity index was calculated for each cement; this was the length of bone directly apposed to cement expressed as a percentage of the total length of the cement surface. Histological examination of implanted tibiae for up to 26 weeks showed that the affinity indices decreased with SG-P content and that those of all the cement groups increased with time. At 26 weeks, Groups 1 and 2 had almost identical affnity indices (79% and 75%; no significant difference) but those of the other groups remained at <50%. Group 2 had better mechanical and handling properties than Group 1, and an SG-P content in the filler of no more than 25% w/w did not interfere strongly with the bioactivity of the cement.

Animals↗
PubMed1995

Effect of varying surface patterns on antibiotic elution from antibiotic-loaded bone cement.

In an effort to improve the antibiotic elution characteristics of the prosthesis of antibiotic-loaded acrylic cement, an in vitro study was conducted. Tobramycin-loaded bone cement blocks of three different surface patterns with different surface area-to-volume ratios were used. The elution of tobramycin over a 2-month period was investigated. There was a gradual decline in the tobramycin elution rate over time. The surface pattern with the increased surface area-to-volume ratio showed a significant increase in the tobramycin elution rate over the first week of the study. The surface pattern with ridges but no change in the surface area-to-volume ratio did not result in a statistically significant increase in the tobramycin elution rate.

Antibiotic Prophylaxis↗
PubMed2005

Effects of synergistic reinforcement and absorbable fiber strength on hydroxyapatite bone cement.

Approximately a million bone grafts are performed each year in the United States, and this number is expected to increase rapidly as the population ages. Calcium phosphate cement (CPC) can intimately adapt to the bone cavity and harden to form resorbable hydroxyapatite with excellent osteoconductivity and bone-replacement capability. The objective of this study was to develop a strong CPC using synergistic reinforcement via suture fibers and chitosan, and to determine the fiber strength-CPC composite strength relationship. Biopolymer chitosan and cut suture filaments were randomly mixed into CPC. Both suture filaments and composite were immersed in a physiological solution. After 1-day immersion, cement flexural strengths (mean +/- SD; n = 6) were: (2.7 +/- 0.8) MPa for CPC control; (11.2 +/- 1.0) MPa for CPC-chitosan; (17.7 +/- 4.4) MPa for CPC-fiber composite; and (40.5 +/- 5.8) MPa for CPC-chitosan-fiber composite. They are significantly different from each other (Tukey's at 0.95). The strength increase from chitosan and fiber together in CPC was much more than that from either fiber or chitosan alone. The composite strength became (9.8 +/- 0.6) MPa at 35-day immersion and (4.2 +/- 0.7) MPa at 119 days, comparable to reported strengths for sintered porous hydroxyapatite implants and cancellous bone. After suture fiber dissolution, long macropore channels were formed in CPC suitable for cell migration and tissue ingrowth. A semiempirical relationship between suture fiber strength S(F) and composite strength S(C) were obtained: S(C) = 14.1 + 0.047 S(F), with R = 0.92. In summary, this study achieved substantial synergistic effects by combining random suture filaments and chitosan in CPC. This may help extend the use of the moldable, in situ hardening hydroxyapatite to moderate stress-bearing orthopedic applications. The long macropore channels in CPC should be advantageous for cell infiltration and bone ingrowth than conventional random pores and spherical pores.

Bone Substitutes↗